UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008772 |
|---|---|
| Receipt number | R000010018 |
| Scientific Title | Clinical trial for soft tissue augmentation by autologous fat injection. |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2012/08/26 15:32:36 |
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Basic information
Public title
Clinical trial for soft tissue augmentation by autologous fat injection.
Acronym
Versatility of autologous fat injection
Scientific Title
Clinical trial for soft tissue augmentation by autologous fat injection.
Scientific Title:Acronym
Versatility of autologous fat injection
Region
| Japan |
Condition
Condition
soft tissue contour defomities.
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe and evaluate the treatment of soft tissue contour defomities using autologous fat injection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of contour defomities.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Application of autologous fat
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with breast-conserving surgery, wanted to improve cosmetic with autologous fat injection.
In patients who underwent breast reconstruction using implants to resection, patients improved cosmetics can be expected by autologous fat injection.
In patients with unilateral facial atrophy progression (Rombergs disease), patients who wish to treatment with autologous fat injection.
In patients who were causing soft tissue contour defomities, such as trauma, wanted to improve cosmetic with autologous fat injyction.
Key exclusion criteria
Patients with the sole purpose of aesthetics.
Patients with serious complications.
Patients with collagen disease, diabetes.
Patients in the oral steroid.
Patients of the patient is determined to breast cancer surgery, a high likelihood of recurrence.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Emiko Aiba |
Organization
Juntendo university
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-0033
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 26 | Day |
Last modified on
| 2012 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010018
